The EU generics market: a Greek perspective

Ahead of his speaking engagement at the Generics &amp, Biosimilars summit 2012, Deepak shares his insights into the current state of the generics industry and how he thinks it will evolve in the future. He also offers his insights on the impact that the downturn of the Greek economy has had on generics.

Please see a transcript of the interview below.

Interview summary

RA: Hello Deepak, thanks for joining me. Could you please start by telling me about your background and your current role.

DM: Hi Rebecca, I am a pharmacist by by education as well as profession. I joined R&amp,D in pharmaceuticals because I was always interested in cooking new recipes (I mean formulations ?). For two years I worked in R&amp,D Panacea biotech India, and later moved to Ranbaxy India and worked for about 9 years in their global R&amp,D center. I currently work in as VP of Product development in Genepharm group and lead their R&amp,D department for Generic product development.

“…affordable pricing of biosimilars is going to be the key factor in determining the success of biosimilars in the market place.”

RA: How do we overcome the challenge of pricing with biosimilars to ensure effective market access?

DM: I really appreciate this question Rebecca and I think it is a very important issue today. In my opinion affordable pricing of biosimilars is going to be the key factor in determining the success of biosimilars in the market place. To be competitive in the market a generic company should target:

(1) A multinational but cost effective-model to exploit the best of every world – this will help it to keep its development cost lower so that it can afford to bring a cost-competitive product to the market.

(2) An efficient, convenient but cost-effective drug delivery device (often an injecting device) is perhaps more important than anything else. Lots of biosimilar companies are focusing on less painful, safer and economical injections so that patients can avoid visits to hospitals and clinics to minimize healthcare cost.

RA: What are the current trends in the EU generics market?

DM: The EU generic market like any other market is severely undero price pressure due to the current economic crisis in EU. The only current good news is that, globally the population is ageing which will keep the volume of medicines high. Most companies that I know have become more selective in choosing the profitable molecules. Focus has now shifted from “number of new approvals” to “potential of margins and profitability” of new development. But most exciting, which is becoming more prominent by every passing day, is the need of product differentiation in some of the non-tender driven generic markets.

“…most companies who were relying on the Greek generics market have taken a big setback in their margins and profitability..”

We at Genepharm have already recognized the importance of product differentiation and many new developments are being based on the super-generic concept. This has really worked well for us. We are however very careful to come up with a patient-oriented or patient-friendly product differentiation.

RA: In Greece what specific challenges are you currently experiencing with the development of generics?

DM: Due to the current economic meltdown in Greece and strong price reduction in generic medicines, most companies who were relying on the Greek generics market have taken a big setback in their margins and profitability. Most Greek companies who were in transition from a “local player” to a “multinational one” were fueling their multinational engines from their local profits. Overall it has been a bad time for most Greek companies especially for their R&amp,D pipeline.

RA: In your opinion what has been the impact of the recent EU legislation on generics?

RA: What advice can you give on overcoming regulatory barriers with generics to gain market access?

DM: I think, champions of product development should first think like champions of regulatory approvals this will make everyone’s life more simple and improve the quality of the products coming to market.

While developing any new products the pharma industry should put itself in the shoes of a regulator who has the responsibility of the safety of millions of lives (patients) while considering the new product for approval . The regulatory requirements will then no longer be seen as barriers by the pharma industry.

RA: Finally, what do you anticipate the future generics market to look like in the EU?

DM: Against popular belief that biosimilars may become very dominant in the global market from 2015, I feel quite the opposite – that small molecules will still be an essential part of our lives purely because of their simplicity of administration. Overall, I feel positive about the future of small molecule generics at least for the next 5–7 years.

Industrial experience: Dr. Murpani spent more than 17 years in R&amp,D driven pharmaceutical companies like Panacea biotech (1996-1997), Ranbaxy (1997-2006) and Genepharm. Presently employed as VP (Product development), with Genepharm, Greece since 2006. He is a Pharmacist by qualification with most of the scientific experience in industrial and business driven generic and super-generic R&amp,D.

In last 12 years, his key focus has been development of novel and patentable platform formulation/ technologies or patent non-infringing formulations for oral solid and liquid dosage forms. Products developed/ commercialized for US and Europe markets includes immediate release, modified release and value added dosage forms registered under Para III, Para IV, Para IV FTF, 505(b)(2) and hybrid generics. NDDS research work in last few years has focused on bio-availability (BA) enhancement using various formulation approaches e.g. gastric retention, complexation with cyclodextrins, polymorphic/ crystal modification of active, lipid based drug delivery, self microemulsifying drug delivery, nanomilling etc. In immediate release field his experience has been more focused on “difficult to handle” immediate release (e.g. immunosuppressants, cytotoxics etc.) or value added dosage forms e.g. effervescent tablets, orally dispersible taste masked tablets, soluble tablets and dispersible tablets.

Do you think that biosimilars will become dominant in the global market after 2015?

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